PE Magazine
This article explores life-cycle activities for machine learning (ML) within regulated life sciences. It positions and contextualizes the life cycle and management of the machine learning subsystem or components within a wider system life cycle. It also gives general descriptions and guidance illustrated by a case study demonstrating a machine learning application to medical image recognition, or software as a medical device (SaMD).
PE Magazine
This article aims to refresh information on open-source software (OSS) within regulated computerized systems that was first discussed in an article in May-June 2010 Pharmaceutical Engineering®. The adoption of OSS advanced since then, and the article explores the importance of recognizing when an organization is relying on OSS and the benefits and risks this brings from a GAMP® 5 perspective.
PE Magazine
IT Services: Applying Good IT Practice and Automation Cover: This article focuses on pragmatic quality- and risk-based approaches to IT infrastructure...
Learning Level: Basic/Intermediate - Analytical laboratories are required to demonstrate the suitability of their equipment during audits and will typically follow USP requirements defined in Chapter <1058> on analytical...
Online Live
Online Live Overview This Virtual course includes the new revised EU GMP Annex 11, and an update on 21 CFR Part 11. This two-day fundamental course* introduces participants to regulatory requirements for computerized...

The US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program promotes a risk-based, product quality–focused, and patient-centric approach to computerized systems. This approach encourages critical thinking based on product and process knowledge and quality risk management over prescriptive documentation-driven approaches.

GAMP® refers to Good Automated Manufacturing Practice. A system for producing quality equipment using the concept of prospective validation following a life cycle model. Specifically designed to aid suppliers and users...